N/A
N=15
G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis
Progressive Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03980145 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Comfortable Walking Speed — .45; .60; .52; .67 meters per second — p=.405
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- G-EO System (Reha Technology AG: Olten, Switzerland) (Device); Conventional Physical Therapy (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfortable Walking Speed |
.45; .60; .52; .67 | .405 |
| PRIMARY Two Minute Walk Test |
66.57; 89.35; 72.62; 93.21 | .369 |
| PRIMARY Modified Fatigue Impact Scale |
50.14; 43.75; 40.71; 34.25; 23.71; 25.88 | .594 |
| PRIMARY Multiple Sclerosis Impact Scale-29 |
65.89; 47.97; 52.32; 33.13; 55.16; 30.56 | .071 |
| PRIMARY Fast Walking Speed |
.55; .81; .63; .84 | .352 |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) |
8.43; 5.88; 7.14; 4.75; 7.57; 4.75 | .117 |
| SECONDARY Short Form McGill Pain Questionnaire |
10.14; 5.00; 8.29; 5.38; 2.57; 1.63 | .239 |
| SECONDARY Late-Life Disability Inventory (LLFDI) |
50.10; 55.21; 49.78; 54.93; 52.72; 60.27 | .136 |
| SECONDARY Late-Life Function Inventory |
43.65; 45.76; 48.13; 53.27 | .338 |
Summary
The logistic advantages and advanced training capabilities of the G-EO System, as well as the benefits reported in other populations, support this strategy as a potentially potent rehabilitation tool for restoring and maintaining function in progressive Multiple Sclerosis (MS). This approach represents a paradigm shifting opportunity for improving current clinical practices for patients with progressive MS. If successful, this project will provide initial evidence for increasing patient access to the G-EO System, and this could be accomplished through "regional technology centers" using a rural health-delivery approach.
There are several novel aspects of the proposed trial: (1) the examination of a novel gait rehabilitation stimulus (G-EO System) that could alter current clinical practices; (2) the focus on patients with progressive MS who have gait impairment (i.e., those who have received minimal research attention), which was recently described as the greatest therapeutic challenge facing the MS community; and (3) a study design that accounts for standard therapy.
Specific Aims: The investigators designed a single-blinded, randomized pilot trial of electromechanically-assisted gait training using the G-EO System in patients with progressive MS with gait disability (EDSS=4.0-7.5).
Specific Aim 1 will establish the safety and feasibility of gait training using the G-EO System.
Specific Aim 2 will determine the efficacy of gait training using the G-EO System for improving mobility, symptomatic, quality of life, and participatory outcomes.
Eligibility Criteria
Inclusion Criteria
- 18-64 years
- Confirmed diagnosis of Primary or Secondary Progressive Multiple Sclerosis (this will be confirmed by the referring physician)
- EDSS 4.0-7.522
- Stable course of disease-modifying therapy over the past 6 months
- Asymptomatic (i.e., no underlying cardiovascular disease)
- Physician approval for exercise
- Willingness to visit the IU Health Neurosciences Center for testing and training
Exclusion Criteria
- Pregnancy
- Current use of dalfampridine (Ampyra®)
- Conventional physical therapy or G-EO training within the past 6 months
- Height 2m
- Body weight >150 kg
- Contraindications to G-EO gait training (e.g., bone instability)
Data sourced from ClinicalTrials.gov (NCT03980145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.